While silicone breast implants have been around since the 1960s, they’ve experienced little technological evolution in the past three decades until the 2010s.

Meanwhile, women around the world face increasing news coverage of breast implant-related side effects – most of which have been linked to one particular implant surface – the macrotextured kind.

But despite mounting evidence that macrotextured implants potentially trigger inflammatory conditions in patients, leading implant manufacturers continue to manufacture, market, and sell 4th and 5th generation implants that haven’t significantly changed since the 1980s.

Such conditions can range from common, low-risk capsular contracture (which is when the natural tissue capsule formed around an implant hardens and contracts) to a form of cancer known as breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL.

In the face of competitors’ complacency, Establishment Labs has sought to make women’s health the focus that drives how implants are designed and manufactured.

We’ve teamed up with the best research-focused institutes and universities – along with the world’s most innovative plastic surgeons – to diligently investigate an under-researched subject: breast implant surfaces, and the ways our immune systems can respond to them.

Our research on implant technologies began a decade and a half ago in 2004. While other manufacturers base their development process almost purely on clinical data, we’ve taken a more holistic approach, basing our 6th generation implant technology on both clinical and scientific research.

You might be wondering what the differences between the two are, and how they matter when it comes to making implants with minimal side effects.

 

Clinical research involves strictly controlled studies of new and emerging treatments in real human patients. It allows doctors to evaluate new forms of treatment, determine how best to apply them in medicine, and provide patients with opportunities to receive the latest, state-of-the-art care.

Basic scientific research, however, is performed in laboratory conditions using beakers and test tubes, not people. Investigators research microscopic phenomena – at the cellular and molecular level of life – to better understand the macroscopic phenomena that occur in humans, such as diseases and disorders.

Our research informed us early on of the inflammatory effects of macrotextured implants, which is why we never chose to make them to begin with. Instead, we’ve focused on creating our biocompatible advanced smooth surface, along with other features that help keep patients safe and beautiful.

Motiva Implants® were designed specifically to minimize the body’s inflammatory reactions – and thus, the conditions associated with them.

 

 

More than a million Motiva Implants® have been used by patients and leading plastic surgeons throughout the 2010s across the globe. Both clinical and scientific publications as well as post-market implant surveillance show that patients with Motiva Implants® experience an overall complication rate of less than 1%.

Learn more about our advanced smooth surface and unique safety features here.

 

 

*Motiva Implants® are not available for sale in US and Canada.

September 26, 2019

Establishment Labs Holdings Inc. (NASDAQ: ESTA) is a global medical technology company focused on women’s health in breast surgery. Women are at the center of everything we do at Establishment Labs and it is our mission to protect their health by offering safe solutions in breast aesthetics and reconstruction. Based on those principles, a decade ago we began conducting research in conjunction with a risk analysis of breast implant safety, ultimately deciding never to manufacture macrotextured breast implants.

On September 26, 2019, the Therapeutic Goods Administration (TGA) in Australia confirmed that Motiva Implants® will not be affected by their investigations and the subsequent regulatory action announced in relation to breast implants and breast tissue expanders sold in Australia. As part of the new TGA requirements, Establishment Labs will provide additional information to practitioners and consumers in Australia and report of adverse event for all of our breast implant and tissue expander devices sold globally.

Motiva Implants® are clearly differentiated from any other available traditional breast implants. Our SmoothSilk® / SilkSurface® shell is classified in the smooth category according to ISO-14607:2018 “Non-active surgical implants – Mammary implants – Particular requirements”, Annex H, Test for surface characteristics, which we had confirmed by independent testing conducted by Laboratoire National de Métrologie et d’Essais (LNE), a renowned third-party laboratory based in France. TGA’s recent announcement is further affirmation of Motiva’s differentiation.

We offer the most comprehensive portfolio of advanced smooth implants, which incorporates our proprietary SmoothSilk® / SilkSurface® nanosurface technology, which has been designed to minimize inflammation and maximize biocompatibility. This is one of just many safety features that we have built into our Motiva Implants® to improve patient safety and aesthetic outcomes.

Our entire portfolio of Motiva Implants® remain available in Australia and across more than 75 countries worldwide.

For additional information about our advanced product portfolio and breast implant safety features, please visit: motiva.health

Read our complete position statement on breast implant safety here.

 

*Motiva Implants® are not available for sale in US and Canada.

July 15, 2019

Establishment Labs Holdings Inc. (NASDAQ: ESTA) is a global medical technology company focused on women’s health in breast surgery. Women are at the center of everything we do at Establishment Labs and it is our mission to protect their health by offering safe solutions in breast aesthetics and reconstruction. Based on those principles, a decade ago we began conducting research in conjunction with a risk analysis of breast implant safety, ultimately deciding never to manufacture macrotextured breast implants.

As a result, the Therapeutic Goods Administration (TGA) in Australia has confirmed that supply of Motiva Implants® will not be affected by their investigations.

Motiva Implants® are clearly differentiated from any other available traditional breast implants. Our SmoothSilk® / SilkSurface® shell is classified in the smooth category according to ISO-14607:2018 “Non-active surgical implants – Mammary implants – Particular requirements”, Annex H, Test for surface characteristics, which we had confirmed by independent testing conducted by Laboratoire National de Métrologie et d’Essais (LNE), a renowned third-party laboratory based in France. TGA’s recent announcement is further affirmation of Motiva’s differentiation.

We offer the most comprehensive portfolio of advanced smooth implants, which incorporates our proprietary SmoothSilk® / SilkSurface® nanosurface technology, which has been designed to minimize inflammation and maximize biocompatibility. This is one of just many safety features that we have built into our Motiva Implants® to improve patient safety and aesthetic outcomes.

Our entire portfolio of Motiva Implants® remain available in Australia and across more than 70 countries worldwide.

For additional information about our advanced product portfolio and breast implant safety features, please visit: motiva.health

Read our complete position statement on breast implant safety here.

 

*Motiva Implants® are not available for sale in US and Canada.

Motiva SmoothSilk®

 

With the continuing news coverage of breast implant-related events, many of us – especially those with breast implants of our own – may be left feeling concerned about the potential risks of having or receiving such devices, and even confused by the often highly technical terms being used in media coverage.

Education is a large, and often overlooked, part of the equation that allows breast reconstruction and augmentation patients to make the safest and most fulfilling choices for themselves.

As Diana Zuckerman, president of the National Center for Health Research in the US, has said to the media, “When women decide to get breast implants for reconstruction after mastectomy or for breast augmentation, they should not be putting their lives at risk…”

We couldn’t agree more. As part of our mandate towards improving women’s health, we’d like to assure women that with the right type of breast implant, it is still very possible to maintain a safe, high quality of life thereafter.

An important factor that can affect long-term health after breast reconstruction or augmentation is the chosen implant’s surface or shell type. While there are several subcategories of surface types, let’s broadly consider textured vs. smooth surfaces for simplicity.

Traditional smooth implants generally better mimic the natural breast since they can move about freely in their pockets after breast augmentation. They can also lead to more implant displacement over time.
There’s a reason we refer to such surfaces as “traditional”: since the 1960s, manufacturers of such implants haven’t delivered significant innovation when it comes to their surface (or other implant-related) technology.

As their name suggests, textured implants have a rougher surface – one that’s sometimes compared to sandpaper. Historically, surgeons have chosen to use this implant surface type due to the “Velcro effect” it achieves by adhering to surrounding tissue more easily, thereby reducing implant sliding or rotation.
But textured implants (especially those that are rougher or “macrotextured”) come with significant safety-related drawbacks. For one, that same Velcro effect can lead to wrinkling or traction rippling (i.e. when an implant strains surrounding tissue, making overlying skin look visibly rippled), which in turn can contribute to implant rupture.

Since textured shells have more surface areas with nooks and crannies, bacteria can more easily adhere to their surfaces as well, leading to increased risk of chronic inflammatory conditions such as late seromas, double capsules, and even an uncommon form of cancer known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). In fact, textured implants are almost exclusively associated with BIA-ALCL since there have been no reported ‘pure’ cases with smooth implants (without a prior history of a textured device).

The good news is that women no longer need to compromise and settle for either implant type if they wish to receive a breast augmentation or reconstruction.
Motiva Implants® offer patients the world’s most comprehensive portfolio of advanced smooth breast implants.

By “comprehensive”, we mean that the product family offers a wide range of implants that come in various projections, volumes, shapes, and gel types (for either more “youthful” or “natural” look, feel, and movement) to customize and create the best possible implant match for every patient’s body.
This product line includes an anatomically shaped smooth implant, which is novel as historically, anatomical implants have only been available with textured surfaces.

And by “advanced smooth”, we’re referring to the Motiva SmoothSilk®/SilkSurface®, one that has been classified as smooth per the ISO-14607:2018 international standard (the same category as traditional smooth implants) but is more advanced than traditional smooth implants in the following ways:
Traditional smooth implants come with reduced risk of chronic inflammatory conditions (such as BIA-ALCL) but increased risk of capsular contracture (an often-painful medical complication in which a large, fibrous capsule forms around the implant and compresses it), while SmoothSilk®/SilkSurface® comes with minimal risk of both.

In fact, SmoothSilk®/SilkSurface® has yielded an extremely low overall complication rate of less than 1% till date. Its uniform, controlled nanosurface is elastic enough that it can be inserted through smaller incisions, which in turn promotes a healthier, smoother post-op recovery process.

“Motiva Implants® go in comfortably through a smaller incision, and we know they cause less inflammation in the body around the actual implant, which again probably confers benefits in avoiding the long-term implant complications,” says Dr. Terrence Scamp, a prominent plastic surgeon in Australia who has worked with a wide range of implant types.

Motiva Implants® have other unique safety features, and its manufacturer Establishment Labs is committed to continuing its mission to further safety in breast surgery for the long run.
Motiva Implants® remain available in 70+ countries and Establishment Labs has not received any warnings or regulatory actions from health authorities. Read more about our position on breast implant safety here.

Use the MotivaImagine Center® Locator to find an experienced plastic surgeon in your area that can help you learn more about Motiva Implants® and assess which implant type would best suit you.

 

*Motiva Implants® are not available for sale in US and Canada.